BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 2948907 · Received February 1, 2013

    Report

    Report Number
    MW5028856
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    October 8, 2012
    Report Date
    February 1, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEM
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VOLUNTARY PRODUCT RECALL BY MFR DUE TO DECREASED TENSILE STRENGTH OF THE PRODUCT. DATES OF USE: (B)(6) 2011 - (B)(6) 2012. DIAGNOSIS OR REASON FOR USE: URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44215 AMERICAN MEDICAL SYSTEMS AMS ADVANCE MALE SLING FTL AMERICAN MEDICAL SYSTEM 725596019

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR